Assessing Connected-Health, Pressure-Monitoring Technology for Improving Compression Therapy in Venous Leg Ulcer Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: A connected-health, pressure-sensing system for monitoring sub-bandage pressure during compression therapy.
- Who it may be relevant to
- Registry conditions: Venous Leg Ulcers (VLUs). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Assessment of a Connected-health, Pressure Monitoring Technology for Improving Clinical Outcomes of Compression Therapy in the Treatment of Venous Leg Ulcers
Overview
This study evaluates the effectiveness of a connected-health, pressure monitoring technology (Tight Alright) to improve clinical outcomes of compression therapy in patients with venous leg ulcers (VLUs). Compression therapy is the standard of care for VLUs, but achieving and maintaining therapeutic sub-bandage pressure is challenging due to patient variability and lack of objective feedback. The Tight Alright system includes a wearable device that measures sub-bandage pressure at multiple points on the leg and transmits data to a mobile app and cloud database, enabling both guided compression application at the point-of-care and guided compression maintenance via remote monitoring. The study will be conducted at Parkview Noble Center for Wound Healing and will include two cohorts: a control group receiving standard unguided compression therapy with blinded device use (i.e. compression pressures will be blinded at the point of care but monitored remotely), and an intervention group using Tight Alright technology to guide compression application and reapplication. Outcomes will include wound healing rates, time to healing, pressure maintenance, patient adherence, and usability. The study aims to determine whether integrating connected-health pressure monitoring can improve consistency of compression therapy, accelerate healing, and enhance patient engagement in the treatment of venous leg ulcers
Interventions
- Device A connected-health, pressure-sensing system for monitoring sub-bandage pressure during compression therapy
The Tight Alright system, developed by FeelTect Limited, consists of a wearable, pressure sensing device that measures sub-bandage pressure at three regions along the length of the lower leg. The wearable device transmits data wirelessly to a mobile app on a smart device, which then displays the data in real-time. The mobile app is also capable of transmitting data to a remote cloud database, via the internet, where it can be viewed on a remote dashboard (i.e., via a secure webpage).
Primary outcome measures
- Percentage area reduction per day [Time frame: From enrollment to the end of treatment at 5 weeks]
Secondary outcome measures (2)
- Average pressure [Time frame: From enrollment to the end of treatment at 5 weeks]
- Percentage of patients healed [Time frame: From enrollment to the end of treatment at 5 weeks]
Eligibility criteria
Inclusion criteria
- Patient of Parkview Noble Center for Wound Healing
- Adults 18+ with venous leg ulcers receiving compression therapy treatment prescribed by outpatient wound clinic.
- Capable of using use a smart device
- Owns a smart phone or device capable of downloading the Mobile App
Exclusion criteria
- <18 years old
- Unable to consent in English
- Cellulitis in affected limb
- Acute deep vein thrombosis in affected limb
- Active malignancy in affected limb
- Prisoners
- Currently enrolled in or has been enrolled in another investigation device or drug trial in the last 30 days
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Parkview Center for Wound Healing — Fort Wayne
Identifiers
NCT: NCT07152717 · NUR25-0409WoundCompress